NCT03858426

Brief Summary

  • Clinical, endoscopic and histological response at 8-12 weeks of induction treatment
  • Clinical, endoscopic and histological response at 6 and 12 months weeks of maintenance treatment
  • Registry of patients treated with two foods elimination diet:
  • Clinical, endoscopic and histological response at 8-12 weeks of induction treatment
  • Identification of food trigger: milk, gluten or milk and gluten
  • Clinical, endoscopic and histological response at one year elimination of food trigger
  • Registry of adverse events
  • Registry of patients treated with swallowed steroids (budesonide or fluticasone):
  • Clinical, endoscopic and histological response at 8-12 weeks of induction treatment
  • Clinical, endoscopic and histological response at 6 months of maintenance steroid treatment
  • Registry of adverse events

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 11, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 28, 2019

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2020

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2022

Completed
Last Updated

February 28, 2019

Status Verified

February 1, 2019

Enrollment Period

1.8 years

First QC Date

October 11, 2018

Last Update Submit

February 26, 2019

Conditions

Eosinophilic Esophagitis

Keywords

Eosinophilic Esophagitis; PPIs, children, elimination diet, topical steroids

Outcome Measures

Primary Outcomes (1)

  • Complete histological remission

    Complete histological remission response defined as ≤5 eosinophils/hpf in all biopsies performed

    12 weeks

Secondary Outcomes (2)

  • Partial histological remission

    12 weeks

  • Clinical remission

    12 weeks

Study Arms (1)

Children with eosinophilic esophagitis

Inclusion criteria: * Children from 1 month to 18 years with a new diagnosis of eosinophilic esophagitis according to recent European guidelines (symptoms of esophageal dysfunction + eosinophilic infiltrate of the esophagus \> 15 eos / CGA) * And they need to start treatment with one of the following options: PPI, diet excluding cow's milk and gluten, or swallowed corticosteroids Exclusion criteria: * Presence of pathological eosinophilia at the gastric or duodenal level (eosinophilic gastroenteritis) * Simultaneous treatment with more than one treatment modality (PPI, empirical elimination diet, swallowed corticosteroids).

Other: no intervention

Interventions

no interventionOTHER

no intervention

Children with eosinophilic esophagitis

Eligibility Criteria

Age1 Month - 18 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Children from 1 month to 18 years with a new diagnosis of eosinophilic esophagitis according to the recent European guidelines

You may qualify if:

  • Children from 1 month to 18 years with a new diagnosis of eosinophilic esophagitis (EoE) according to the recent European guidelines (symptoms of esophageal dysfunction + eosinophilic infiltrate of the esophagus \> 15 eos / CGA)
  • And that they need to start treatment with any of the following options: PPI, diet excluding cow's milk and gluten, or swallowed corticosteroids .

You may not qualify if:

  • Presence of pathological eosinophilia at the gastric or duodenal level (eosinophilic gastroenteritis)
  • Simultaneous treatment with more than one treatment modality (PPI, empirical elimination diet, swallowed corticosteroids).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario Puerta de Hierro Majadahonda

Madrid, 28222, Spain

RECRUITING

MeSH Terms

Conditions

Eosinophilic Esophagitis

Condition Hierarchy (Ancestors)

EsophagitisEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesGastroenteritisEosinophiliaLeukocyte DisordersHematologic DiseasesHemic and Lymphatic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Central Study Contacts

Carolina Gutierrez-Junquera, MD, PHD

CONTACT

+34911916437carolina.gutijun@salud.madrid.org

Belén Ruiz-Antorán, MD, PHD

CONTACT

+34911917479mariabelen.ruiz@salud.madrid.org

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 11, 2018

First Posted

February 28, 2019

Study Start

January 1, 2019

Primary Completion

November 1, 2020

Study Completion

July 30, 2022

Last Updated

February 28, 2019

Record last verified: 2019-02

Locations

ES(1)